Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that its
novel dMAb antibody and DNA vaccine targeting the chikungunya virus
(CHIKV) provided 100% protection against a lethal virus challenge
in mice. This breakthrough data was published in the latest issue
of The Journal of Infectious Diseases in a paper, “Rapid and
long-term immunity elicited by DNA encoded antibody prophylaxis and
DNA vaccination against Chikungunya virus,” prepared by Inovio
authors and their academic collaborators. While conventional
vaccine and marketed monoclonal antibody technologies have shown
limited ability to provide an effective solution to CHIKV to date,
Inovio’s DNA vaccine and dMAb products show potential, separately
and in combination, to offer immediate and long term protection to
large populations from CHIKV infection.
Over the years, CHIKV outbreaks have occurred in
Africa, Asia, Europe, and throughout the Indian and Pacific Oceans,
with local transmission in over 43 countries infecting millions of
people. In late 2013, CHIKV was found for the first time in the
Americas on islands in the Caribbean and spreading to other parts
of the western hemisphere, including the United States. Along with
a dramatic increase in cases and geographic spread of CHIKV
infection and disease there has been a reported increase in
morbidity and mortality, suggesting increased virulence. The
concern for even greater potential global outbreaks underscores the
need for targeted anti-viral interventions.
Inovio previously published that its SynCon® DNA
vaccine for CHIKV provided durable 100% protection in mice. In this
study, a single intramuscular injection of a DNA plasmid encoding a
monoclonal antibody targeting CHIKV protected mice from a lethal
dose of the virus. The protection expressed by these dMAb
antibodies was very rapid, with 100% survival in mice challenged
with lethal enhanced CHIKV disease as early as two days after dMAb
product administration. In comparison, vaccine-driven protection
can take weeks to months to reach peak efficacy levels, but
providing better long term protection compared to a dMAb product.
Inovio’s study demonstrates that its CHIKV dMAb antibody and DNA
vaccine could be used as an ideal combination to provide both rapid
short-term as well as long-term protection.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “This study is significant for two reasons. First, this is
our third published study (two previous in HIV and dengue)
demonstrating the protective efficacy of our dMAb products. Inovio
is rapidly building its dMAb product development program targeting
cancer and infectious diseases. Notably, DARPA is providing us over
$56 million to specifically develop dMAb products against
influenza, antibiotic-resistant bacteria, and Ebola.
“Second, this study demonstrates that Inovio’s
dMAb products and DNA vaccines could be a powerful combination to
provide robust immediate and long term protection not only for
CHIKV but also other infectious diseases. Inovio is the only
organization to report such results in any disease by using a
DNA-based monoclonal antibody, with published preclinical data in
dengue as well, and we now are creating Zika, MERS, and Ebola dMAb
products. Our MERS and Ebola vaccines are in phase I clinical
studies and we will advance our Zika vaccine to phase I before year
end. We also aim to test further combinations.”
Chikungunya does not often result in death, but
the symptoms can be severe and disabling and include extreme pain,
headache, muscle pain, joint swelling, or rash. The chikungunya
virus is carried by the same mosquito species which carry Zika,
dengue and West Nile virus (WNV). Inovio previously published
robust immunogenicity and challenge protection data for its SynCon®
CHIKV, dengue, and WNV vaccine candidates. Inovio’s chikungunya
program builds on its extensive preclinical development experience
with various mosquito-borne viruses.
Paper Abstract
Background: Vaccination and
passive antibody therapies are critical for controlling infectious
diseases. Passive antibody administration has limitations including
the necessity for purification and the delivery of multiple
injections required for efficacy. Vaccination is associated with a
lag phase before generation of immunity. Novel approaches reported
here utilize the benefits of both methods for the rapid generation
of effective immunity. Methods: An antibody-based
prophylaxis/therapy entailing the electroporation-mediated delivery
of synthetic plasmids, encoding biologically active
anti-Chikungunya virus envelope mAb (designated dMAb), was designed
and evaluated for anti-viral efficacy as well as for the ability to
overcome shortcomings inherent with conventional active vaccination
by a novel passive immune-based strategy. Results:
One intramuscular injection of the CHIKV-dMAb produced antibodies
in vivo more rapidly than active vaccination with a CHIKV-DNA
vaccine. This dMAb neutralized diverse CHIKV clinical isolates and
protected mice from viral challenge. Combinations of both afford
rapid as well as long-lived
protection. Conclusions: We report that a DNA
based dMAb strategy induces rapid protection against an emerging
viral infection, which can be combined with DNA vaccination
providing a uniquely both short term and long-term protection
against this emerging infectious disease. These studies have
implications for pathogen treatment and control strategies.
About Inovio’s dMAb
Technology
Unlike conventional monoclonal technology, which
involves constructing protein-based antibodies and manufacturing
them in cell culture in a complex and costly process, Inovio’s
patent-protected DNA-based monoclonal antibody technology encodes
the DNA sequence for a specific monoclonal antibody in a highly
optimized plasmid, which would be delivered directly into a
subject’s arm using electroporation. Cells in the body would then
produce the encoded monoclonal antibody molecules, with intended
functional activity including high antigen-binding and
neutralization capabilities against the targeted disease.
Monoclonal antibodies offer the benefit of inducing a rapid onset
of the immune response. The current monoclonal antibody product
market is well over $50 billion. Overall, Inovio’s dMAb technology
may provide clear advantages over conventional monoclonal antibody
technology, including faster development, easier product
manufacturing, and more favorable pharmacokinetics.
About Inovio Pharmaceuticals,
Inc.
Inovio is taking immunotherapy to the next level
in the fight against cancer and infectious diseases. We are the
only immunotherapy company that has reported generating T cells in
vivo in high quantity that are fully functional and whose killing
capacity correlates with relevant clinical outcomes with a
favorable safety profile. With an expanding portfolio of immune
therapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
MedImmune, Roche, The Wistar Institute, University of Pennsylvania,
DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines
Trial Network, National Cancer Institute, U.S. Military HIV
Research Program, and University of Manitoba. For more information,
visit www.inovio.com.
This press release contains certain
forward-looking statements relating to our business, including our
plans to develop electroporation-based drug and gene delivery
technologies and DNA vaccines, our expectations regarding our
research and development programs and our capital resources. Actual
events or results may differ from the expectations set forth herein
as a result of a number of factors, including uncertainties
inherent in pre-clinical studies, clinical trials and product
development programs (including, but not limited to, the fact that
pre-clinical and clinical results referenced in this release may
not be indicative of results achievable in other trials or for
other indications, that the studies or trials may not be successful
or achieve the results desired, including safety and efficacy for
VGX-3100 and INO-3112, that pre-clinical studies and clinical
trials may not commence or be completed in the time periods
anticipated, that results from one study may not necessarily be
reflected or supported by the results of other similar studies and
that results from an animal study may not be indicative of results
achievable in human studies), the availability of funding to
support continuing research and studies in an effort to prove
safety and efficacy of electroporation technology as a delivery
mechanism or develop viable DNA vaccines, our ability to support
our broad pipeline of SynCon® active immune therapy and vaccine
products, our ability to advance our portfolio of immune-oncology
products independently, the ability of our collaborators to attain
development and commercial milestones for products we license and
product sales that will enable us to receive future payments and
royalties, the adequacy of our capital resources, the availability
or potential availability of alternative therapies or treatments
for the conditions targeted by the company or its collaborators,
including alternatives that may be more efficacious or
cost-effective than any therapy or treatment that the company and
its collaborators hope to develop, our ability to enter into
partnerships in conjunction with our research and development
programs, evaluation of potential opportunities, issues involving
product liability, issues involving patents and whether they or
licenses to them will provide the company with meaningful
protection from others using the covered technologies, whether such
proprietary rights are enforceable or defensible or infringe or
allegedly infringe on rights of others or can withstand claims of
invalidity and whether the company can finance or devote other
significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of
the company's technology by potential corporate or other partners
or collaborators, capital market conditions, the impact of
government healthcare proposals and other factors set forth in our
Annual Report on Form 10-K for the year ended December 31, 2015,
and other regulatory filings from time to time. There can be no
assurance that any product in Inovio's pipeline will be
successfully developed or manufactured, that final results of
clinical studies will be supportive of regulatory approvals
required to market licensed products, or that any of the
forward-looking information provided herein will be proven
accurate.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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